Antibodies are powerful tools for in vitro diagnostics (IVD) research and are the basis of numerous therapeutics. The use of antibodies in IVD is having a tremendous medical impact. There is an ever-increasing need for antibodies for IVD applications. Creative Biolabs is well equipped and versed in antibody development to assist our customers' IVD research and project development. Our scientists have established an advanced IVD antibody development platform to support the discovery and production of polyclonal and monoclonal antibodies (mAbs) with high affinity and high specificity. Diverse cutting-edge technologies, such as hybridoma technology, antigen-specific single B cells sorting technology and display technologies including phage display, mammalian cell and yeast display, have been employed for IVD mAbs antibody discovery. After that, a range of expression systems, such as bacteria, yeast, mammalian cell, baculoviral insect cell, plant expression system and cell-free systems, are available for the production of high-quality IVD antibodies.

Expression Systems for IVD mAbs Production

Custom IVD Antibody Production Services

Custom IVD Antibody Production Services
  • Bacteria expression system

Bacteria are very attractive for use in antibody production because of their fast growth, ease of manipulation, relatively well-known information and much lower antibody production costs. Production of recombinant antibody fragments in Escherichia coli has been focused mainly on two major formats of antibody fragments: single-chain variable fragment (scFv) and antigen-binding fragment (Fab). Creative Biolabs has established several systems for antibody fragment production, such as high expression systems with T7 RNA polymerase gene promoter, coexpression of foldases or molecular chaperones to prevent misfolding and aggregation of antibody fragments.

  • Yeast expression system

Although the pattern of N-glycan in yeast is quite different from the human counterparts, yeasts have their own glycosylation machinery. With further optimization of the host and the production process, yeast has great potential to become a viable platform to produce competitive yields of complex and functional antibodies. At Creative Biolabs, significant progress has been made in the engineering of yeast cells (Saccharomyces cerevisiae and Picchia pastoris) for enhanced production of IVD antibodies.

Custom IVD Antibody Production Services
Custom IVD Antibody Production Services
  • Mammalian cell expression system

The most prominent host cell lines for antibody production are CHO, NS0, Sp2/0, HEK 293 and PER.C6. 1) CHO-based mAb production processes typically reach the highest product titers with 1 g/L (batch) and 1-10 g/L (fed-batch). 2) The most prominent characteristic of NS0 and Sp2/0 is that they express the two predominant immunogenic glycan epitopes for humans, galactose-alpha1,3-Gal (alpha-gal) and N-glycolyl-neuraminic acid (Neu5Gc). 3) HEK and PER.C6 cells are used to produce antibodies with human identical glycosylation. HEK293 cells are specially applied for transient gene expression and reach mAb expression levels only in the low tens to hundreds of milligrams per liter range during batch cultivation and up to 0.6 g/L (fed-batch). Regarding PER.C6 cells, product yields are more in the range of CHO-based processes with mAb titers of 0.5 g/L (batch), 8 g/L (fed-batch), and even 27 g/L (perfusion). Creative Biolabs offers mammalian cell transient expression and stable cell line development for the production of IVD mAbs with a volume that could reach 1000 L and even more.

  • Baculoviral insect cell expression system

Insect cells are a very powerful tool for the expression of large, highly processed antibodies because of their ability to perform signal-peptide cleavage, N- and O-linked glycosylation and efficient extracellular secretion. Under the control of very strong viral promoters, it is possible to transiently express large DNA fragments by using baculoviruses. What's more, the glycosylation patterns have been shown to differ somewhat as compared to mammalian cells. Spodoptera frugiperda (SF) and Trichoplusia ni are the main insect cell lines used for antibody production. Sf9, Sf21 and "High Five" cells are available at Creative Biolabs to support the production of IVD mAbs.

Custom IVD Antibody Production Services
Custom IVD Antibody Production Services
  • Plant expression system

The plant as a bioreactor for the mAb production has several advantages, which include the lack of animal pathogenic contaminants, low cost of production, and ease of agricultural scale-up compared to other currently available systems. Thus, plants are considered to be a potential alternative to compete with other systems. Creative Biolabs has developed an advanced antibody expression platform based on Nicotiana benthamiana and N. tabacum to produce IVD antibodies.

  • Cell-free expression systems

Cell-free systems are emerging as an attractive alternative for the production of antibodies due to their flexible nature without any cell membrane constraints. Cell-free systems based on cell lysates derived from different sources, and with batch-to-batch consistency, have acted as a catalyst for the cell-free synthesis of target antibodies. Creative Biolabs provides several cell-free systems based on the cell lysate of prokaryotic or eukaryotic cells for the production of IVD antibodies.

Custom IVD Antibody Production Services

Custom IVD Antibody Production Services at Creative Biolabs

Creative Biolabs provides high-efficiency antibody production services in a wide range of expression systems. To support the manufacture of IVD antibody, Creative Biolabs has established professional bacteria, yeast, mammalian cell, baculoviral insect cell, plant expression system and cell-free expression systems to providing one-stop services from project design, sequence optimization, gene synthesis, vector construction to high-quality antibody production and purification. Our custom antibody production services include high-throughput low-amount antibody production and large-scale antibody production service (up to 100 g). Our antibody production services also include both production and purification of recombinant IgG, scFv/Fab, bispecific antibody (BsAb) and single domain antibodies (sdAbs).

Highlights

  • Providing one-stop services from project design, sequence optimization, gene synthesis, vector construction, high-quality antibody production and purification.
  • Multi-isotypes antibodies, including antibodies with full length, such as human IgGs (IgG1, IgG2, IgG3, IgG4), mouse IgGs (IgG1, IgG2a, IgG2b, IgG3), rat IgGs (IgG1, IgG2a, IgG2b, IgG2c), rabbit IgG, canine IgG, IgA, IgM and IgE, and antibodies with partial length, such as scFv, Fab, F(ab)2 and BsAb.
  • High purity: up to 99%
  • Low endotoxin level
  • Comprehensive quality control (QC) analysis, including UV, SDS-PAGE, ELISA, HPLC, etc.
  • Powered by a proven, first-in-class technology
  • Best after-sale service

IVD research increasingly relies on mAbs. Creative Biolabs is pleased to present world-leading IVD antibody production services. For more detailed information, please feel free to contact us for a detailed quote and further discussion with our scientists.

References

  1. Ho, S.C.; et al. Generation of monoclonal antibody-producing mammalian cell lines. Pharmaceutical bioprocessing. 2013, 1(1):71-87.
  2. Palmberger, D.; et al. Insect cells for antibody production: evaluation of an efficient alternative. Journal of biotechnology. 2011, 153(3-4):160-6.

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